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510(k) Data Aggregation

    K Number
    K982148
    Device Name
    PRODIGY 2
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    1998-07-31

    (43 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K950215
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Prodigy 2 is a dental composite restorative material intended to be used in Class I and Class II cavity situations. However, Prodigy 2 may also be used in all classes of cavities, wherever an additional resistance to pack is deemed necessary.

    Device Description

    The device is a visible light cured dental composite restorative material. Due to the material's unique handling characteristics, Prodigy 2 is suggested for use in Class I and Class II cavity situations. However, Prodigy 2 may also be used in all classes of cavities, wherever an additional resistance to pack is deemed necessary.

    AI/ML Overview

    This document is a 510(k) summary for a dental composite restorative material called "Prodigy 2." It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the way a medical device typically would for diagnostic or therapeutic efficacy. This submission is for a material, not a diagnostic or AI-driven device.

    Therefore, I cannot provide the requested information. The provided text is a regulatory filing for a dental restorative material, focusing on its substantial equivalence to existing products rather than performance metrics against specific acceptance criteria for a diagnostic or AI device.

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